We develop and manage Validation Master Plans (VMPs), test scripts, and protocols for GMP compliance. Our documentation ensures traceability, alignment with user requirements, and inspection readiness.

Using tools like FMEA and PHA, we identify and mitigate risks throughout the CQV process – ensuring lifecycle control strategies are in place and aligned with regulatory expectations.

We support early-stage design reviews, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT) to verify design intent, streamline commissioning, and reduce rework.

Our team designs and executes process and cleaning validation studies using a Quality by Design (QbD) approach to establish Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).

We lead the development and verification of sterilization and decontamination cycles (e.g., SIP, CIP, VHP), including thermal mapping, recovery studies, and validation of TC/BI placements.

Support for instrument qualification and analytical method validation in QC labs and production environments – aligned with regulatory standards for accuracy and reliability.

Ongoing support for equipment and system requalification, including scheduled periodic reviews, deviation management, and change control strategies.

We assess data integrity practices and deploy custom cloud-based tools for managing changes, deviations, and documentation across capital and site projects.